Standards and labels

• EN 13485:2016

  EN 13485:2016 is a standard for a Quality Management System for Medical Devices. It sets out the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. This standard is used to demonstrate a company's ability to meet specific quality and safety requirements for the design, production, installation and servicing of medical devices. Test results can include audits and inspections of the organization's facilities, processes, and products to ensure compliance with the standard.

  Reach out to ask about the standard test results

• EN 14079:2003

  EN 14079:2003 is a European standard for air terminals (air diffusers) used in ventilation systems. It sets requirements for the design, construction, testing and marking of air terminals to ensure they can withstand pressure, air leakage, and fire. Tests include leakage, pressure and fire resistance test. The standard applies to both circular and rectangular air terminals and it also specifies requirements for the documentation of the air terminal, including a declaration of performance, and the marking of the air terminal with the manufacturer's name or trademark and product information.

  Reach out to ask about the standard test results